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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04704024
Other study ID # IRB-300006586
Secondary ID 5R01HD101545
Status Recruiting
Phase Phase 3
First received
Last updated
Start date September 3, 2021
Est. completion date December 31, 2025

Study information

Verified date October 2023
Source University of Alabama at Birmingham
Contact Jodie Dionne, MD, MSPH
Phone 2059756530
Email jdionne@uabmc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Hepatitis B virus is an infection that can be easily transmitted from women to newborns at the time of delivery. Our objective is to identify novel options that are effective and safe in preventing perinatal transmission of hepatitis B in Africa. The REVERT-B study (Reducing Vertical Transmission of Hepatitis B in Africa) is a clinical trial designed to test a new strategy of using antiviral medication in high-risk pregnant women and newborns to reduce the risk of hepatitis B transmission. The study will measure efficacy, safety, tolerability and adherence to medication.


Description:

The REVERT-B trial is a multi-center, phase III, randomized 2x2 factorial study designed to test the efficacy of early maternal TDF vs standard duration and neonatal 3TC prophylaxis compared to matching placebo in preventing HBV MTCT. Eligible pregnant women with HBV in prenatal care (n=450) will be randomized 1:1:1:1 to one of four maternal and neonatal prophylaxis combinations (shown as A-D in the figure below). Women will initiate daily oral TDF early (2nd trimester) or at the standard time per WHO guidelines (3rd trimester) and will continue TDF until delivery. The current WHO standard of care in pregnant women with HBV (EAg+) in Cameroon is TDF prophylaxis from 28 weeks until delivery. Newborns will receive liquid 3TC or matching placebo for the first six months of life to provide coverage until the vaccine series is complete. All infants in the study will be offered the 4-dose HBV vaccine series starting at birth. The 2x2 factorial design allows for two simultaneous studies where we first assess efficacy of early maternal prophylaxis (Aim 1) and secondarily assess efficacy of neonatal prophylaxis (Aim 2). The study endpoint for both aims is the MTCT rate (proportion of infants HBsAg+) at 6-9 months of age. Women and infants will be followed until 6-9 months after delivery and subaims will assess safety and adherence to maternal TDF and neonatal 3TC. Plasma testing will be used to measure medication adherence.


Recruitment information / eligibility

Status Recruiting
Enrollment 450
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender Female
Age group 16 Years to 50 Years
Eligibility Inclusion Criteria: - prenatal clinic patient, - age =16 years, - 14-32 weeks gestational age according to clinic dating based on LMP or ultrasound, - active hepatitis B with risk of vertical transmission (HBsAg+ AND HBeAg+ or HBV DNA >1000 IU/ML), - plan to receive follow up care and deliver at study facility, - capable of providing informed consent. Exclusion Criteria: - HIV positive (according to HIV antibody testing performed at the initial prenatal visit) - known liver cirrhosis or end-stage liver disease, - elevated liver enzymes (ALT >5x upper limit of normal), - elevated serum creatinine (>1.4 mg/dl) - currently taking tenofovir medication - allergy or intolerance to tenofovir study medication, - known fetal anomaly in the current pregnancy, - clinical illness requiring hospitalization at the time of enrollment - evidence of early labor at the time of enrollment.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Tenofovir Disoproxil Fumarate
oral TDF medication 300 mg daily
Lamivudine Oral Solution
Oral lamivudine with weight-based dosing BID from birth until 6 months of age

Locations

Country Name City State
United States University of Alabama at Birmingham Birmingham Alabama

Sponsors (2)

Lead Sponsor Collaborator
University of Alabama at Birmingham Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Vertical Transmission of hepatitis B Infection The proportion of infants with Hepatitis B surface antigen positivity (SAg+) 6-9 months of age
Primary Virologic Suppression The proportion of women with a suppressed HBV DNA viral load (<10 IU/mL). at delivery
Secondary In utero HBV infection HBV infection (SAg+, PCR positive) at birth
Secondary Maternal Adherence to TDF HPLC measurement of serum 8 weeks after starting medication
Secondary Maternal Adherence to TDF HPLC measurement of serum at delivery
Secondary Infant Adherence to 3TC HPLC measurement of serum 12 weeks after starting 3TC
Secondary Infant Adherence to 3TC HPLC measurement of serum 24 weeks after starting 3TC
Secondary Hepatitis B Flare Increase in ALT (>2x ULN) after stopping TDF at delivery 12 weeks after delivery
Secondary Hepatitis B Flare Increase in ALT (>2x ULN) after stopping TDF at delivery 24 weeks after delivery
Secondary Preterm delivery Delivery <37 weeks gestational age assessed at delivery
Secondary Composite Adverse Birth Outcomes PTD, SAB, IUFD, neonatal death during pregnancy or up to 28 days after delivery
Secondary Incident HIV infection during pregnancy Maternal HIV infection with seroconversion to positive test at delivery
Secondary Retention in Prenatal Care at least 4 ANC visits after 28 weeks GA assessed at time of delivery
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